Study Comparing Sacituzumab Tirumotecan and Pembrolizumab Combination to Pembrolizumab Alone for Treating Mismatch Repair Proficient Endometrial Cancer
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT06952504
This clinical trial is exploring whether a combination of two drugs, sacituzumab tirumotecan and pembrolizumab, can help patients with advanced or returning endometrial cancer live longer without the disease worsening, compared to using pembrolizumab alone.
Patient Parameters
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Program Overview
This study is focused on finding better treatments for people with a specific type of endometrial cancer, known as proficient mismatch repair (pMMR) endometrial cancer, which is either advanced or has come back after treatment. Endometrial cancer starts in the lining of the uterus. The term 'proficient mismatch repair' means that certain proteins, which help fix DNA errors, are present in the cancer cells. The study is testing two drugs: sacituzumab tirumotecan (sac-TMT), which targets and destroys cancer cells, and pembrolizumab, an immunotherapy drug. Researchers want to see if combining these drugs helps patients live longer without their cancer getting worse, compared to using pembrolizumab alone.
Description
Participants in this study will first go through an Induction Phase, which includes six cycles of treatment. Each cycle lasts three weeks and involves receiving pembrolizumab along with either carboplatin and paclitaxel or docetaxel. If the cancer does not progress during this phase, participants will move to the Maintenance Treatment Phase. Here, they will be randomly assigned to receive either the combination of pembrolizumab and sac-TMT or pembrolizumab alone. If the cancer progresses, participants may enter the Subsequent Treatment Phase, where they will be randomly assigned to receive either the combination of pembrolizumab and sac-TMT or sac-TMT alone.
Eligibility Criteria
Key inclusion criteria include but are not limited to:
- Has a histologically confirmed diagnosis of primary advanced or recurrent endometrial carcinoma that has been confirmed as proficient mismatch repair (pMMR)
- Has radiographically evaluable disease, with measurable Stage III or either measurable or non-measurable Stage IV or recurrent disease per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1), as assessed by the investigator.
- Has received no prior systemic therapy for endometrial carcinoma except the following conditions as pre-specified by the protocol: 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of curative-intent, prior radiation with or without radiosensitizing chemotherapy if >2 weeks before the start of induction treatment, or prior hormonal therapy for treatment of endometrial carcinoma that was discontinued ≥1 week before the start of induction treatment
Key exclusion criteria include but are not limited to:
- Has carcinosarcoma, neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of sarcomas
- Has endometrial carcinoma of any histology that is mismatch repair deficient (dMMR)
- Is a candidate for curative-intent surgery or curative-intent radiotherapy at the time of enrollment
- Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Human Immunodeficiency Virus-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Received prior therapy in any setting with any of the following: anti-programmed cell death 1 protein, anti-programmed cell death ligand 1, anti-programmed cell death ligand 2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor; trophoblast cell surface antigen 2-targeted antibody drug conjugate; or topoisomerase I inhibitor-containing antibody drug conjugate
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of South Alabama, Mitchell Cancer Institute ( Site 6033) | 36604 | Mobile | Alabama |
| Alaska Women's Cancer Care ( Site 6036) | 99508 | Anchorage | Alaska |
| University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 6020) | 92868 | Orange | California |
| MedStar Washington Hospital Center ( Site 5005) | 20010 | Washington D.C. | District of Columbia |
| Florida Cancer Specialists - South ( Site 7003) | 33901 | Fort Myers | Florida |
| UF Health Davis Cancer Pavilion and Shands Med Plaza ( Site 6026) | 32608 | Gainesville | Florida |
| Mount Sinai Cancer Center ( Site 6031) | 33140 | Miami Beach | Florida |
| Florida Cancer Specialists - North ( Site 7002) | 33705 | St. Petersburg | Florida |
| Florida Cancer Specialists East ( Site 7001) | 33401 | West Palm Beach | Florida |
| St. Joseph's/Candler Health System ( Site 6021) | 31405 | Savannah | Georgia |
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